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CMS rejects new safety standards petition for genetic-testing labs.

In a joint press release issued in September, the Genetics and Public Policy Center, the Genetic Alliance, and Public Citizen announced that the Centers for Medicare and Medicaid Services (CMS) rejected on Aug. 30, 2007, their September 2006 petition calling for the agency to exercise its authority under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) to strengthen standards for genetictesting laboratories. CMS also had received letters from nearly 100 organizations, including healthcare providers, patients, and industry, requesting that the agency create enhanced genetic-testing regulations. The petition sought to increase the use of proficiency testing by requesting the creation of a "specialty" for genetic testing. Citing cost concerns, the agency told petitioners in a recent letter that it would not pursue the safety standards.

CLIA '88 requires the Secretary of the Department of Health and Human Services to set standards for laboratories to ensure their quality, including standards for "proficiency testing." Proficiency testing provides independent confirmation that the lab can get the right answer reliably when performing laboratory tests. CMS, however, has not mandated participation in proficiency testing for genetic-testing laboratories. Genetic tests are currently available clinically for more than 1,100 diseases.

In denying the petition for rulemaking, CMS stated that few proficiency-testing programs exist and that the barriers to expanding the number were "technological and financial," rather than regulatory. According to the press release, the College of American Pathologists (CAP) now offers proficiency testing for more than two dozen genetic tests, including widely used tests such as cystic fibrosis and Factor V Leiden, but laboratories currently are not required to enroll in them. Mandatory requirements would result in more proficiency tests being developed, the petition argued.

To support its contention that developing new proficiency-testing programs is too difficult, CMS points to its experience with Pap smears, stating that it took 17 years from the passage of CLIA '88 to develop a nationwide proficiency-testing program. CMS' response also dismissed reports from three federal advisory groups over the past decade recommending that the agency strengthen genetictesting oversight.
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Title Annotation:News; United States. Centers for Medicare and Medicaid Services
Publication:Medical Laboratory Observer
Geographic Code:1USA
Date:Nov 1, 2007
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